Galmed's Aramchol misses in Phase IIa for HIV-associated NAFLD

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) said Aramchol arachidyl amino cholanoic acid missed the primary endpoint in the Phase IIa ARRIVE trial to treat HIV-associated lipodystrophy and non-alcoholic fatty liver disease (NAFLD). The company said it has no further development plans for the product in the indication.

On the 50-patient trial's primary endpoint, once-daily 600 mg oral Aramchol did not significantly reduce liver fat content as measured by MRI proton density fat fraction (MRI-PDFF) from baseline to week 12 vs. placebo. Secondary endpoints in the double-blind, U.S. trial include serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels. The trial was sponsored by the University of California San Diego...